Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000877886
Ethics application status
Approved
Date submitted
16/08/2012
Date registered
17/08/2012
Date last updated
24/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving older patients’ safety in Western Australian
hospitals – reducing falls in rehabilitation units.
Scientific title
A cluster randomised controlled trial evaluating the effect of providing tailored multimedia patient education for cognitively intact older patients in addition to usual care in aged care rehabilitation units on rates of falls compared to providing usual care alone.
Secondary ID [1] 281002 0
Nil
Universal Trial Number (UTN)
U1111-1133-3825
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental Falls 287136 0
Condition category
Condition code
Injuries and Accidents 287457 287457 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients continue to receive their usual care. In addition to usual care, eligible patients admitted to the intervention wards will receive a multimedia falls prevention education package (DVD and workbook) with further face to face follow up education (including workbook completion and goal setting) with a health professional. The DVD will be shown to the patient at the bedside. Education session lengths will range between 15 and 35 minutes. The total number of sessions to deliver the entire educational content of the program is intended to occur within 4 sessions (range 1 to 4 sessions depending on the individual). The health professional delivering the intervention will have discretion over the frequency and duration of each follow up education session depending on individual patient and circumstance. However, the educational content is the same for all patients receiving the intervention. This flexibility in the frequency and duration of delivery is reflective of differences between and within individual patients' conditions such that on one day they may not feel well enough to participate in an education session, or only be able to manage a short duration of discussion, but on other days may tolerate longer sessions. Staff receive ongoing information about which patients have received the education and what the outcomes are for that individual patient, as well as any ward implications identified for that patient. There is not a maximum duration for the intervetion although it is expected that patients would receive a maximum of 5 sessions.
All wards commence in the control conditions at time 0. Two wards crossover into the intervention after 10 weeks and so on until all wards by 41 weeks have entered the intervention arm of the trial.
Intervention code [1] 285459 0
Behaviour
Comparator / control treatment
Patients admitted to wards who are receiving usual care will continue to receive the usual falls prevention practices. This is likely to consist of detailed falls risk screening, assessment and management of identified risk factors, ward level strategies including falls stickers and handover alerts, individual falls prevention treatment as each patient required and ongoing staff training in the area of falls prevention.
Control group
Active

Outcomes
Primary outcome [1] 287728 0
Rates of falls on all wards enrolled the trial (event rate of falls measured in events per time units) assessed by hospital data reporting numbers of patients on the trial wards, number of occupied bed days of all patients on the trial wards, and number of falls that occur on the wards during the observation period. Falls data also captured by hand searching of patient case notes throughout the obervation period of the trial.
Timepoint [1] 287728 0
These rates will be calculated at the conclusion of the trial observation period, that is at the conclusion of 50 weeks.
Secondary outcome [1] 298727 0
Rates of falls on individual sites Accidental falls (event rate of falls measured in events per time units)- assessed by hospital data reporting numbers of patients on the trial wards, number of occupied bed days of all patients on the trial wards, and number of falls that occur on the wards during the observation period. Falls data also captured by hand searching of patient case notes throughout the obervation period of the trial.
Timepoint [1] 298727 0
The falls rates for individual sites will be calculated at the end of the trial observation period, that is at the conclusion of 50 weeks.

Eligibility
Key inclusion criteria
Admission to ward enrolled in the trial - 8 aged care geriatric rehabilitation wards
Individual patients deemed eligible on ward to receive intervention - The patient level inclusion criteria are that the patient must be over 60 years old, cognitively intact as defined by MMSE >23/30 OR AMTS 7/10 AND final confirmation by the treating registrar that patient is cognitively intact. The patients’ projected admission must be longer 2 days on the ward.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of dementia or other cognitive impairment, presence of delirium diagnosed by registrar on ward

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Gatekeeper consent for ward participation in trial will be obtained from unit managers of the 8 wards prior to the commencement of the trial. The name of the ward allocated to each of the positions will be concealed in opaque envelopes numbered 1 to 8. Randomisation will occur at the ward level (cluster randomisation). All wards will start in the usual care condition for the first ten weeks. Each of the 8 wards will be randomised by project team member not directly involved in the running of these wards to enter the intervention condition at either week eleven, twenty-one, thirty-one or forty-one. Two wards will be randomised to enter the intervention condition at each of the aforementioned weeks. Once a ward has crossed over from the control condition to the intervention condition, that ward will remain in the intervention condition for the remainder of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generation will be used to allocate each ward to crossover positions 1 through 8. Two wards will crossover from the usual care condition to the intervention condition at each ten week interval in order of their position allocation (i.e. wards allocated to crossover positions 1 and 2 will commence the intervention condition at week eleven, wards allocated to positions 3 and 4 will commence the intervention condition at week twenty-one etc.).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Wedge design - over 50 weeks 2 sites enter trial at 10 week intervals.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2013
Actual
13/01/2013
Date of last participant enrolment
Anticipated
28/12/2013
Actual
27/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 285793 0
Government body
Name [1] 285793 0
Department of Health Western Australia
Country [1] 285793 0
Australia
Primary sponsor type
University
Name
The University of Notre Dame Australia
Address
19 Mouat Street, (PO Box 1225), Fremantle, WA 6959
Country
Australia
Secondary sponsor category [1] 284616 0
Individual
Name [1] 284616 0
Dr Nicholas Waldron
Address [1] 284616 0
Health Networks Branch
Department of Health, Western Australia
189 Royal Street, West Perth, Western Australia


Aged Care and Rehabilitation Department
Armadale Health Service
3056 Albany Highway,
Armadale, Perth, WA 6112
Country [1] 284616 0
Australia
Other collaborator category [1] 277005 0
Individual
Name [1] 277005 0
Associate Professor Terry P. Haines
Address [1] 277005 0
Director, Allied Health Research Unit, Southern Health
Director of Research,
Southern Physiotherapy Clinical School,
Physiotherapy Department, Monash University
Victoria 3800 Australia
Country [1] 277005 0
Australia
Other collaborator category [2] 277006 0
Individual
Name [2] 277006 0
Professor Christopher Etherton-Beer
Address [2] 277006 0
School of Medicine and Pharmacology, Royal Perth Hospital Unit
Principal researcher WA Centre for Health & Ageing
Level 6 Ainslie House
48 Murray Street Perth WA 6004
University of Western Australia
35 Stirling Highway
Crawley WA 6009 Australia
Country [2] 277006 0
Australia
Other collaborator category [3] 277007 0
Individual
Name [3] 277007 0
Dr Steven McPhail
Address [3] 277007 0
Senior Research Fellow
Centre for Functioning and Health Research, Queensland Health and Institute of Health and Biomedical Innovation and School of Public Health,
Queensland University of Technology
c/o PO Box 6053
Buranda, QLD 4102 Australia
Country [3] 277007 0
Australia
Other collaborator category [4] 277008 0
Individual
Name [4] 277008 0
Dr Katherine Ingram
Address [4] 277008 0
Geriatrician, Department of Health Western Australia
Institution: Sir Charles Gairdner Hospital
Department of Health, Western Australia
189 Royal Street, East Perth, WA 6004 Australia
Country [4] 277008 0
Australia
Other collaborator category [5] 277009 0
Individual
Name [5] 277009 0
Professor Leon Flicker
Address [5] 277009 0
Professor Geriatric Medicine,
Director WA Centre for Health and Ageing
The University of Western Australia
Level 6 Ainslie House
48 Murray Street Perth WA.
University of Western Australia
35 Stirling Highway
Crawley WA 6009 Australia
Country [5] 277009 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287803 0
The University of Notre Dame Australia HREC
Ethics committee address [1] 287803 0
Ethics committee country [1] 287803 0
Australia
Date submitted for ethics approval [1] 287803 0
01/09/2012
Approval date [1] 287803 0
13/09/2012
Ethics approval number [1] 287803 0
012069F
Ethics committee name [2] 287807 0
Sir Charles Gairdner Hospital HREC
Ethics committee address [2] 287807 0
Ethics committee country [2] 287807 0
Australia
Date submitted for ethics approval [2] 287807 0
01/10/2012
Approval date [2] 287807 0
25/10/2012
Ethics approval number [2] 287807 0
Ethics committee name [3] 287849 0
South Metropolitan Area health Service HREC
Ethics committee address [3] 287849 0
Ethics committee country [3] 287849 0
Australia
Date submitted for ethics approval [3] 287849 0
01/11/2012
Approval date [3] 287849 0
29/11/2012
Ethics approval number [3] 287849 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34558 0
Dr Anne-Marie Hill
Address 34558 0
The University of Notre Dame Australia School of Physiotherapy PO Box 1225 19 Mouat St Fremantle WA 6959
Country 34558 0
Australia
Phone 34558 0
+61 8 94330239
Fax 34558 0
Email 34558 0
[email protected]
Contact person for public queries
Name 17805 0
Dr Anne-Marie Hill
Address 17805 0
The University of Notre Dame Australia
School of Physiotherapy
PO Box 1225
19 Mouat St
Fremantle WA 6959
Country 17805 0
Australia
Phone 17805 0
+61 8 94330239
Fax 17805 0
+61 8 94330210
Email 17805 0
[email protected]
Contact person for scientific queries
Name 8733 0
Dr Anne-Marie Hill
Address 8733 0
The University of Notre Dame Australia
School of Physiotherapy
PO Box 1225
19 Mouat St
Fremantle WA 6959
Country 8733 0
Australia
Phone 8733 0
+61 8 94330239
Fax 8733 0
+61 8 94330210
Email 8733 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFall rates in hospital rehabilitation units after individualised patient and staff education programmes: A pragmatic, stepped-wedge, cluster-randomised controlled trial.2015https://dx.doi.org/10.1016/S0140-6736%2814%2961945-0
N.B. These documents automatically identified may not have been verified by the study sponsor.